85/100 · Critical
Manufactured by BluePoint Laboratories
High Seriousness in Adverse Reactions for Diclofenac Sodium Topical Gel, 1%
323,718 FDA adverse event reports analyzed
Last updated: 2026-05-12
DICLOFENAC SODIUM TOPICAL GEL, 1% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BluePoint Laboratories. Based on analysis of 323,718 FDA adverse event reports, DICLOFENAC SODIUM TOPICAL GEL, 1% has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DICLOFENAC SODIUM TOPICAL GEL, 1% include DRUG INEFFECTIVE, PAIN, FATIGUE, RHEUMATOID ARTHRITIS, ABDOMINAL DISCOMFORT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DICLOFENAC SODIUM TOPICAL GEL, 1%.
Diclofenac Sodium Topical Gel, 1% has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 323,718 adverse event reports for this medication, which is primarily manufactured by Bluepoint Laboratories.
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 78.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A significant proportion of reported reactions are serious, with 78.6% classified as such.
The most common reactions include pain, fatigue, and rash, indicating potential skin and musculoskeletal issues. There are multiple reports of serious conditions like systemic lupus erythematosus and pericarditis, suggesting potential systemic risks.
Patients taking Diclofenac Sodium Topical Gel, 1% should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Diclofenac sodium topical gel should be used with caution in patients with known allergies or hypersensitivity to NSAIDs, and should be avoided in patients with active peptic ulcers or gastrointestinal bleeding. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Diclofenac Sodium Topical Gel, 1% received a safety concern score of 85/100 (high concern). This is based on a 78.6% serious event ratio across 33,672 classified reports. The score accounts for 323,718 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 21,527, Male: 7,825, Unknown: 39. The most frequently reported age groups are age 43 (1,907 reports), age 44 (1,734 reports), age 40 (1,045 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 33,672 classified reports for DICLOFENAC SODIUM TOPICAL GEL, 1%:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Diclofenac sodium topical gel should be used with caution in patients with known allergies or hypersensitivity to NSAIDs, and should be avoided in patients with active peptic ulcers or gastrointestinal bleeding.
If you are taking Diclofenac Sodium Topical Gel, 1%, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, rheumatoid arthritis, abdominal discomfort. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosage and duration of use as directed by a healthcare provider to minimize the risk of adverse reactions. Monitor for any signs of serious reactions such as rash, swelling, or gastrointestinal issues, and seek medical attention if they occur. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of diclofenac sodium topical gel, and any new or severe adverse reactions should be reported to the FDA's MedWatch program.
The FDA has received approximately 323,718 adverse event reports associated with Diclofenac Sodium Topical Gel, 1%. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Diclofenac Sodium Topical Gel, 1% include Drug Ineffective, Pain, Fatigue, Rheumatoid Arthritis, Abdominal Discomfort. By volume, the top reported reactions are: Drug Ineffective (7,369 reports), Pain (7,120 reports), Fatigue (6,730 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Diclofenac Sodium Topical Gel, 1%.
Out of 33,672 classified reports, 26,461 (78.6%) were classified as serious and 7,211 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Diclofenac Sodium Topical Gel, 1% break down by patient sex as follows: Female: 21,527, Male: 7,825, Unknown: 39. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Diclofenac Sodium Topical Gel, 1% adverse events are: age 43: 1,907 reports, age 44: 1,734 reports, age 40: 1,045 reports, age 59: 668 reports, age 58: 442 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Diclofenac Sodium Topical Gel, 1% adverse event reports is Bluepoint Laboratories. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Diclofenac Sodium Topical Gel, 1% include: Rash, Systemic Lupus Erythematosus, Alopecia, Pemphigus, Glossodynia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Diclofenac Sodium Topical Gel, 1% to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Diclofenac Sodium Topical Gel, 1% has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. A significant proportion of reported reactions are serious, with 78.6% classified as such.
Key safety signals identified in Diclofenac Sodium Topical Gel, 1%'s adverse event data include: Systemic lupus erythematosus and pericarditis are key safety signals indicating potential severe systemic reactions.. Multiple reports of gastrointestinal issues, including ulcers and perforation, suggest significant risks in this area.. Reports of liver injury and increased liver enzymes indicate potential hepatotoxicity.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Diclofenac sodium topical gel should be used with caution in patients with known allergies or hypersensitivity to NSAIDs, and should be avoided in patients with active peptic ulcers or gastrointestinal bleeding. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Diclofenac Sodium Topical Gel, 1%.
Follow the prescribed dosage and duration of use as directed by a healthcare provider to minimize the risk of adverse reactions. Monitor for any signs of serious reactions such as rash, swelling, or gastrointestinal issues, and seek medical attention if they occur.
Diclofenac Sodium Topical Gel, 1% has 323,718 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and rash, indicating potential skin and musculoskeletal issues. The volume of reports for Diclofenac Sodium Topical Gel, 1% reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of diclofenac sodium topical gel, and any new or severe adverse reactions should be reported to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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